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Home » Akebia draws CRL for vadadustat in CKD anemia
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Akebia draws CRL for vadadustat in CKD anemia

March 30, 2022
By Randy Osborne
Opinion on Wall Street said the matter could have gone either way, but in the end Akebia Therapeutics Inc.’s vadadustat, a HIF prolyl-hydroxylase inhibitor for anemia caused by chronic kidney disease (CKD), garnered a complete response letter (CRL) instead of approval from the FDA. The news slammed Akebia shares (NASDAQ:AKBA), which closed at 82 cents, down $1.61, or 66%. Specifically, the agency said that the data in the NDA do not support a favorable benefit-risk assessment of vadadustat in dialysis-dependent (DD) and non-DDs patients.
BioWorld Regulatory Genitourinary/sexual function U.S. FDA

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